Management of Cervical Intraepithelial Neoplasia Grade 2

Phase 4

Completed

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Procedure: Excision of the lesion; Other: Follow-up for spontaneous regression of the lesion

• Registration Number: NCT00733109
• Lead Sponsor: Universidade Cidade de Sao Paulo

Brief Summary

The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.

Detailed Description

Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy.

The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2006-07
• Study Completion: 2007-07
• Status Verified: 2008-08
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Last Update Submitted: 2010-01-08
• Last Update Posted: 2010-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Histological CIN2 diagnosis

Exclusion Criteria

• Previous CIN treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
excision of the lesion	Excision of the lesion	-
espontaneous regression	Follow-up for spontaneous regression of the lesion	-

Primary Outcome Measures

Name	Time	Method
43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9%	12 months

Trial Locations

Locations (1)

Leonor Mendes de Barros Maternity Hospital; 🇧🇷 São Paulo, Brazil